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Sleep app shows promise for fibromyalgia sufferers

NCT ID NCT05962138

Symptom relief Sponsor: University of Oxford Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a digital sleep therapy program called Sleepio can improve quality of life, sleep, and thinking in people with fibromyalgia. 80 participants were randomly assigned to use Sleepio or receive standard sleep advice. Researchers measured changes in symptoms using online questionnaires and some participants also had sleep tracking or brain scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Digital Cognitive Behavioural Therapy for Insomnia (Sleepio)
What this could lead to
If it works, this could offer a non-drug way to ease fibromyalgia symptoms like poor sleep and brain fog.
What could go wrong
This is a small, early feasibility study, so results may not apply to everyone. The intervention only targets sleep, not pain directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Jun 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Clinical diagnosis of fibromyalgia * Concomitant insomnia, frequent waking in the night or early morning waking * Self-reported difficulties with concentration or memory * Reliable internet access Exclusion Criteria: * Patients with a poor understanding of English. * Patients with known neurological or psychiatric conditions (other than depression or anxiety) likely to independently affect the results of pain assessment, for example peripheral diabetic neuropathy in the opinion of the research team * Major neuropsychiatric disorder (bipolar disorder, schizophrenia or psychotic spectrum disorders) * Epilepsy * Cognitive impairment, dementia or neurodegenerative disorder * Recent or planned surgery * Current or planned night-time shift work * Sleep disorders such as sleep apnoea, restless leg syndrome, circadian rhythm disorder, or parasomnia * Taking prescribed sleep medications on more than 2 nights in past 2 weeks * Currently receiving other psychological therapy for insomnia * Pregnant or lactating

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Conditions

The condition(s) this trial relates to.

fibromyalgia Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

Contacts and locations

Locations

  • University of Oxford

    Oxford, OX3 9DU, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.